Hope for motherhood: study tests pausing breast cancer meds for pregnancy

NCT ID NCT02308085

Disease control Sponsor: ETOP IBCSG Partners Foundation Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether young women with early-stage, hormone-sensitive breast cancer can temporarily stop their hormone therapy to try to get pregnant without raising their risk of cancer coming back. It involves 518 women aged 18 to 42 who have already been on hormone therapy for at least 18 months. The goal is to see if a pregnancy pause is safe and to track fertility and pregnancy outcomes.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

518 people

The number who actually took part.

Started

Dec 2014

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 42 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 and ≤ 42 years at enrollment. * Has received adjuvant endocrine therapy (SERM alone, GnRH analogue plus SERM or AI) for ≥18 months but ≤30 months for early breast cancer. Note: Patients who have received neo/adjuvant endocrine treatment within a clinical trial and patients who have received pharmaco-prevention are eligible. * The adjuvant endocrine therapy must have stopped within 1 month prior to enrollment. * Patient wishes to become pregnant. Note: Patients who have undergone oocyte/embryo/ovarian tissue cryopreservation at breast cancer diagnosis and/or have a previous history of assisted reproductive technology (ART) are eligible. * Breast cancer for which patient is receiving endocrine therapy must have been histologically-proven stage I-III, endocrine-responsive (i.e., estrogen and/or progesterone receptor positive, according to local definition of positive, determined using immunohistochemistry (IHC)), and treated with curative intent. Note: * Patients with synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) are eligible. * Patient with invasive breast cancer or synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) during pregnancy are eligible. * Patients with BRCA1/2 mutations are eligible. * Patients could have received neo/adjuvant chemotherapy, or other systemic therapy (e.g., neo/adjuvant HER2-targeted therapy) according to institutional policy and patient's desire. * Patient must be premenopausal at breast cancer diagnosis, as determined locally and documented in patient record. * Patient must be without clinical evidence of loco-regional and distant disease, as evaluated according to institutional assessment standards and documented in the patient record. * Written informed consent (IC) for trial participation must be signed and dated by the patient and the investigator prior to enrollment. * Written consent to biological material submission, indicating the patient has been informed of and agrees to tissue and blood material use, transfer and handling, must be signed and dated by the patient and the investigator prior to any procedures specific for this trial. * The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines. * Patient must be accessible for follow-up. Exclusion Criteria: * Post-menopausal patients at BC diagnosis, as determined locally. * History of hysterectomy, bilateral oophorectomy or ovarian irradiation. * Patients with current local, loco-regional relapse and/or distant metastatic breast cancer. * Patients with a history of prior (ipsi- and/or contralateral) invasive BC. * Patients with previous or concomitant non-breast invasive malignancy. * Exceptions are limited exclusively to patients with the following previous malignancies, if adequately treated: basal or squamous cell carcinoma of the skin, in situ non-breast carcinoma, contra- or ipsilateral in situ breast carcinoma, stage Ia carcinoma of the cervix. * Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient's safety. * Patients with a history of noncompliance to medical treatments and/or considered potentially unreliable. * Patients with psychiatric, addictive, or any disorder that would prevent compliance with protocol requirements.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early breast cancer

Contacts and locations

Locations

AO Universitaria Ospedale Di Circolo e Fondazione

Varese, 21100, Italy
APHP, Tenon Hospital in Paris

Paris, France
Abbott-Northwestern Hospital, 800 East 28th Street

Minneapolis, Minnesota, 55407, United States
American University of Beirut Medical Center

Beirut, Lebanon
Asan Medical Center

Seoul, South Korea
Azienda Sanitaria di Bolzano

Bolzano, 39100, Italy
Bon Secours Memorial Regional Medical Centre

Mechanicsville, Virginia, 23116, United States
Bon Secours Saint Francis Medical Centre

Midlothian, Virginia, 23114, United States
Bon Secours Saint Mary's Hospital

Richmond, Virginia, 23223, United States
Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States
Brust-Zentrum AG

Zurich, 8008, Switzerland
Brustzentrum Thurgau - Obstetrics and Gynecology

Frauenfeld, Switzerland
Brustzentum Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland
C.H.U. Sart-Tilman

Liège, 4000, Belgium
CHA-Hopital Du St-Sacrement

Québec, Quebec, G1S 4L8, Canada
CHCVs Hôpital de Sion - Service d'oncologie ambulatoire

Sion, 736, Switzerland
CHUM - Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada
Carle Cancer Centre

Urbana, Illinois, 61801, United States
Carle Physician Group - Effingham

Effingham, Illinois, 62401, United States
Carle on Vermilion

Danville, Illinois, 61832, United States
Case Western Reserve University

Cleveland, Ohio, 44106, United States
Cedars Sinai Medical Centre

Los Angeles, California, 90211, United States
Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada
Centre Oscar Lambret

Lille, 59020, France
Centro di Riferimento Oncologico

Aviano, 33081, Italy
Chagrin Highlands

Orange, Ohio, 44122, United States
Chaim Sheba Medical Center

Tel Litwinsky, 5265601, Israel
Champalimaud Cancer Center - Breast Cancer Unit

Lisbon, Portugal
Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States
Clinique St.Elizabeth

Namur, 5000, Belgium
Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium
Cliniques Universitaires Saint-Luc Brussels

Brussels, Belgium
Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain
Complejo Hospitalario de Navarra

Pamplona, Spain
Dana Farber Cancer Institute

Boston, Massachusetts, 02215-5450, United States
Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States
Debrecen University Dep. of Oncology

Debrecen, Hungary
Dickstein Cancer Treatment Centre

White Plains, New York, 10601, United States
Doctor's Hospital of Laredo

Laredo, Texas, 78045, United States
Emory University

Atlanta, Georgia, 30322, United States
Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States
Essentia Health Cancer Center

Duluth, Minnesota, 55805-1951, United States
Fairview Southdale Hospital

Edina, Minnesota, 55435, United States
Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States
French Lyon Cancer Center

Lyon, 69373, France
Galway University Hospital

Galway, Ireland
Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States
Greater Baltimore Medical Centre

Baltimore, Maryland, 21204, United States
Greenville Health System Cancer Institute-Butternut

Greenville, South Carolina, 29605, United States
Greenville Health System Cancer Institute-Eastside

Greenville, South Carolina, 29611, United States
Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, 29605, United States
Greenville Health System Cancer Institute-Greer

Greer, South Carolina, 29650, United States
Greenville Health System Cancer Institute-Seneca

Seneca, South Carolina, 29672, United States
Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, 29307, United States
Helen F. Graham Cancer Center

Newark, Delaware, 19713, United States
Hennepin County Medical Center - Cancer Center

Minneapolis, Minnesota, 55415, United States
Hospital Clinico San Carlos

Madrid, Spain
Hospital Clinico Universitario Lozano Blesa

Zaragoza, Spain
Hospital Clinico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain
Hospital Clinico Universitario Virgen de la Victoria

Málaga, 29010, Spain
Hospital General Universitario de Valencia - Servico Oncologia

Valencia, Spain
Hospital General de Catalunya

Barcelona, Spain
Hospital Quiron Sagrado Corazon

Seville, Spain
Hospital Son Espases, Palma de Mallorca

Palma, Spain
Hospital Universitario Central de Asturias

Oviedo, Spain
Hospital Universitario Donostia

Donostia / San Sebastian, Spain
Hospital Universitario HM Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)

Madrid, 28050, Spain
Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain
Hospital Universitario de Fuenlabrada

Madrid, Spain
Hospital Virgen De La Salud

Toledo, Spain
Huntsman Cancer Institute / University of Utah

Salt Lake City, Utah, 84112, United States
IHA Hematology Consultants-Brighton

Brighton, Michigan, 48114, United States
IHA Hematology Consultants-Canton

Canton, Michigan, 48188, United States
IHA Hematology Consultants-Chelsea

Chelsea, Michigan, 48118, United States
IHA Hematology Oncology Consultants-Ann Arbor

Ypsilanti, Michigan, 48198, United States
Indiana University

Indianapolis, Indiana, 46202, United States
Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland
Institut Bergonie

Bordeaux, 33076, France
Institut Jules Bordet

Brussels, Belgium
Institute of Oncology & Radiology of Serbia

Belgrade, Serbia
Institute of Oncology Ljubljana - Medical Oncology Department

Ljubljana, Slovenia
Instituto Catalán de Oncología de Gerona Hospital

Girona, Spain
Istituto Europeo di Oncologia (IEO)

Milan, 20141, Italy
Istituto Nazionale Ricerca Cancro

Genova, Italy
Istituto Oncologico della Svizzera Italiana (IOSI)

Bellinzona, Switzerland
Istituto scientifico Romagnolo per lo studio e la cura

Meldola, Italy
John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States
Johns Hopkins University

Baltimore, Maryland, 21218, United States
Kamiiida Daiichi General Hospital

Nagoya, 463-0802, Japan
Kansai Rosai Hospital

Amagasaki, Hyōgo, 660-8511, Japan
Kantonspital Baden AG

Baden, 5404, Switzerland
Kyoto University Hospital

Kyoto, Japan
LKH Salzburg

Salzburg, 5020, Austria
Laso General Hospital, First Department of Medical Oncology

Athens, Greece
Leiden University Medical Centre, Albinusdreef 2, Postbus 9600

Leiden, 2300 RC, Netherlands
Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, United States
Mattoon Charleston Primary Care

Mattoon, Illinois, 61938, United States
Mayo Clinic

Rochester, Minnesota, 55902, United States
Med. Univ. Klinik f. Chir

Vienna, 1090, Austria
Medical Oncology Hematology Consultants PA

Newport, Delaware, 19713, United States
Mercy Hospital

Coon Rapids, Minnesota, 55433, United States
Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States
Montefiore Medical Center - Einstein Campus, 1695 Eastchester Road

The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus, 111 East 210th Street

The Bronx, New York, 10467, United States
Montefiore Medical Center-Weiler Hospital

The Bronx, New York, 10461, United States
Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada
Multimedica Spa

Castellanza, Vareze, Italy
NHO Kyushu Cancer Centre, 3-1-1 Notame Minami-ku Fukuoka-shi

Fukuoka, 811-1395, Japan
NHO Osaka National Hospital

Ōsaka, Japan
NHO Shikoku Cancer Center

Matsuyama, Japan
National Cancer Center Hospital

Tokyo, Japan
National Cancer Center for Global Medicine

Tokyo, Japan
NorthShore Medical Centre

Skokie, Illinois, 60076, United States
NorthShore University Health System - Glenbrook Hospital

Glenview, Illinois, 60026, United States
NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States
NorthShore Unversity Health System - Highland Park Hospital

Highland Park, Illinois, 60035, United States
Northwestern University

Evanston, Illinois, 60201, United States
Norwegian Radium Hospital (Oslo University)

Oslo, Norway
Odette Cancer Centre - Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada
Ohio State University

Columbus, Ohio, 43210, United States
Okayama University Hospital

Okayama, Japan
OnCare Hawaii Inc - POB I

Honolulu, Hawaii, 96813, United States
OnCare Hawaii-Kuakini

Honolulu, Hawaii, 96817, United States
Oncocare Bern

Bern, 3012, Switzerland
Ospedale Belcolle di Viterbo

Viterbo, Italy
Ospedale degli Infermi - S. C. Oncologia Medica

Biella, Italy
Ospedale di Prato

Prato, Firenze, Italy
Ospedale di Trento

Trento, Trento, 38122, Italy
Park Nicollet Methodist Hospital

Saint Louis Park, Minnesota, 55343, United States
Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States
Queen's Medical Centre

Honolulu, Hawaii, 96813, United States
Regina Elena National Cancer Institute

Rome, Italy
Regional Hematology Oncology Practice Associates

Newport, Delaware, 19713, United States
Regions Hospital

Saint Paul, Minnesota, 55101, United States
Rigshospitalet

Copenhagen, 2100, Denmark
Rocky Mountain Cancer Center

Boulder, Colorado, 80303, United States
SCL Health Saint Joseph Hospital

Denver, Colorado, 80218, United States
SUNY Upstate Medical University

Syracuse, New York, 13210, United States
Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48103, United States
Saint Joseph Mercy Hospital - Brighton

Brighton, Michigan, 48114, United States
Saint Joseph Mercy Hospital - Chelsea

Chelsea, Michigan, 48118, United States
Saint Joseph Mercy Hospital- Canton

Canton, Michigan, 48188, United States
Salvatore Maugeri Foundation - Medical Oncology Unit

Pavia, 27100, Italy
Samsung Medical Center

Seoul, 06351, South Korea
Sanford Bismark Medical Centre

Bismarck, North Dakota, 58501, United States
Sanford Cancer Centre Oncology Clinic

Sioux Falls, South Dakota, 57104, United States
Sanford Clinic North - Bemidji

Bemidji, Minnesota, 56501, United States
Sanford Medical Centre

Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Centre

Fargo, North Dakota, 58102, United States
Sanford USD Medical Centre - Sioux Falls

Sioux Falls, South Dakota, 57104, United States
Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States
Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan
Seoul National University Hospital

Seoul, South Korea
Shaare Zedek Medical Center

Jerusalem, Israel
Sharp Memorial Hospital

San Diego, California, United States
Showa University Hospital

Tokyo, Japan
Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States
Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States
Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, 06824, United States
Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611, United States
Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, 06418, United States
Smilow Cancer Hospital-Orange Care Center

Orange, Connecticut, 06477, United States
Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, 06790, United States
Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, 06708, United States
Social Medical Corporation Hakuaikai Sagara Hospital

Kagoshima, Japan
Southeastern Medical Oncology Centre

Clinton, North Carolina, 28328, United States
Southeastern Medical Oncology Centre

Goldsboro, North Carolina, 27534, United States
Southeastern Medical Oncology Centre

Jacksonville, North Carolina, 28546, United States
Southeastern Medical Oncology Centre

Wilson, North Carolina, 27534, United States
Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States
Spital STS AG Onkologiezentrum Thun-Berner Oberland

Thun, Canton of Bern, 3600, Switzerland
St John of God Subiaco Hospital

Perth, Western Australia, 6008, Australia
St John's Hospital

Maplewood, Minnesota, 55109, United States
St Luke's International Hospital

Tokyo, Japan
St Marianna University School of Medicine Hospital

Kawasaki, Japan
St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada
St Vincent's University Hospital

Dublin, Ireland
St. James's Hospital

Dublin, Ireland
Stanford Cancer Institute

Palo Alto, California, 94305, United States
Straub Clinic and Hospital

Honolulu, Hawaii, 96701, United States
The Cancer Institute Hospital of JFCR

Tokyo, Japan
The Carle Foundation Hospital

Urbana, Illinois, 61801, United States
Tohoku University Hospital

Sendai, Japan
Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada
Toranomon Hospital

Minato-ku, Tokyo, 105-8470, Japan
U.O Medicina Oncologica Ospedale di Carpi

Carpi, Modena, 41012, Italy
UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
UO Oncologia, Rimini Hospital

Rimini, 47923, Italy
UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States
UZ Leuven

Leuven, 3000, Belgium
Univ. Klinik f. Frauenheilkunde Innsbruck

Innsbruck, 6020, Austria
Univ. Klinik f. Frauenheilkunde u. Geburtshilfe

Graz, 8036, Austria
Universitario Virgen del Rocio

Seville, 41013, Spain
University General Hospital of Heraklion

Stavrakia, Crete, 71110, Greece
University Hospital Geneva

Geneva, 1211, Switzerland
University Hospital Limerick

Limerick, Ireland
University Hospital Waterford

Waterford, Ireland
University Hospital Zurich

Zurich, 8091, Switzerland
University Hospital of Lausanne (CHUV) BH06 - Oncology Department

Lausanne, Switzerland
University of Colorado Cancer Centre - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States
University of Eastern Piedmont

Novara, 28100, Italy
University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131, United States
University of Tsukuba

Tsukuba, Japan
University of Vermont Medical Centre

Burlington, Vermont, 05401, United States
University of Washington Medical Center

Seattle, Washington, 98195, United States
Universitätsspital Basel

Basel, 4031, Switzerland
Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 1M9, Canada
Weill Medical College of Cornell University

New York, New York, 10065, United States
Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States
Yale University - Yale Cancer Centre

New Haven, Connecticut, 06520, United States
Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, 06473, United States

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